# K023511: Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 5, 2002 after 15 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002531 (2000). 1 ancestor in all.
74 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002531: Excelart with Pianissimo, Model MRT-1501/P3, Toshiba America Mri, Inc. (2000) Summary page 3.

## Most influential descendants
- K032490: Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2 (2003), 73 descendants of its own
- K060003: Excelart Vantage ZGV (2006), 69 descendants of its own
- K063361: Excelart Vantage Atlas, Model MRT-1503 (2006), 68 descendants of its own
- K080038: Vantage Titan, Model MRT-1504/S3 (2008), 61 descendants of its own
- K102489: Vantage Titan 3T (2011), 56 descendants of its own

## Recalls of this device
- Oct 6, 2004 · Not classified · Z-0270-05: Software defect causes images to be rotated 180 degrees.
- Jun 7, 2004 · Not classified · Z-1045-04: Wrong positioning may cause patient burns.

## Indications for use
Imaging of The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { KO0253 I } Fluid Visualization { KO0253 1 } 2D / 3D Imaging { KO0253 1} MR Angiography / MR Vascular Imaging (KO02531 } BIood Oxygenation Level Dependent (BOLD) imaging (KO0253 1 } Perfusion / Diffusion Imaging { K9938O3, KO0253 1 } Proton Spectroscopy (K010129)

Source page: https://510kreport.com/device/K023511
Methodology: https://510kreport.com/methodology